No­var­tis bur­nish­es prospects for its big asth­ma drug with pos­i­tive PhI­II da­ta from a sim­i­lar treat­ment

Amber Tong

Editor

No­var­tis has some good news to share on the asth­ma front as it sets the scene for a block­buster Phase III read­out.

The star to­day is low dose QMF149, a com­bo of the long-act­ing be­ta ag­o­nist (LA­BA) in­da­caterol ac­etate and the cor­ti­cos­teroid mometa­sone furoate. The once-dai­ly in­hala­tion beat a cor­ti­cos­teroid monother­a­py on all pri­ma­ry and sec­ondary end­points, in­clud­ing forced ex­pi­ra­to­ry vol­ume and asth­ma con­trol as mea­sured by a ques­tion­naire.

Vas Narasimhan Linkedin

The QUARTZ study rep­re­sents a pre­lude to much more sig­nif­i­cant re­sults for QVM149, one of sev­en po­ten­tial block­busters CEO Vas Narasimhan has tapped for 2019 (with 18 more to fol­low in the years to come). QVM149 is a triple that adds a long-act­ing mus­carinic re­cep­tor an­tag­o­nist (LAMA) to the two ac­tive in­gre­di­ents in QMF149. Both the triple and the dou­ble are de­liv­ered with the Breezhaler de­vice, which No­var­tis has used for COPD.

Just days ago, No­var­tis teased some Phase II da­ta show­ing that QVM149 beat Ad­vair — the stan­dard-of-care and one of Glax­o­SmithK­line’s big mon­ey mak­ers for years — head-to-head. In­ves­ti­ga­tors not­ed that both dos­es of the drug notched sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments of peak FEV1 com­pared to twice-​dai­ly sal­me­terol/flu­ti­ca­s­one pro­pi­onate.

For the 12-week tri­al with QMF149, on the oth­er hand, lung func­tion was mea­sured by trough FEV1 — tak­en ap­prox­i­mate­ly 24 hours af­ter the last ad­min­is­tra­tion of the drug, as op­posed to with­in a few hours in peak FEV1. The least squares mean treat­ment dif­fer­ence was 0.182 L, (95% CI: 0.148, 0.217; p < 0.001). There were al­so im­prove­ments in evening peak ex­pi­ra­to­ry flow of 26.1 L/min com­pared to MF alone (95% CI, 21.0, 31.2).

Oliv­er Ko­rn­mann IKF Pneu­molo­gie Frank­furt

In terms of asth­ma con­trol, pa­tients on the com­bo scored an av­er­age of 0.218 low­er on a 7-point ques­tion­naire than the com­para­tor arm af­ter 12 weeks (95% CI: -0.293, -0.143; p < 0.001). In ad­di­tion, a greater pro­por­tion among them had an im­prove­ment of or above 0.5 on the ques­tion­naire, which tracks symp­toms. (74.7% vs 64.9%, re­spec­tive­ly; odd ra­tio: 1.69, 95% CI: 1.23, 2.33).

“Fixed-dose com­bi­na­tion in­halers may of­fer ad­van­tages to peo­ple with asth­ma by sim­pli­fy­ing com­plex in­haler reg­i­mens, es­pe­cial­ly when they can be dosed once dai­ly which can there­fore fur­ther re­duce the bur­den of the dis­ease,” said Oliv­er Ko­rn­mann at the Uni­ver­si­ty Hos­pi­tal Mainz, Ger­many.

No­var­tis has sub­mit­ted both QMF149 and QVM149 to the EMA for re­view while ex­pect­ing late-stage da­ta on QVM149.

AUTHOR

Editor

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

John Carroll

Editor & Founder

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Jason Mast

Associate Editor

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

Natalie Grover

Reporter

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Recursion Pharmaceuticals

Salt Lake City, UT

John Carroll

Editor & Founder

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Natalie Grover

Reporter

Amber Tong

Editor

Jason Mast

Associate Editor

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communicationslast month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

John Carroll

Editor & Founder

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

John Carroll

Editor & Founder

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

New York, NY

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

John Carroll

Editor & Founder

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

Natalie Grover

Reporter

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

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